Edwards Lifesciences has ‘key events’ around TAVR this week

Edwards Lifesciences is planning some important TAVR reveals during the PCR London Valves 2017 course that is underway. The Irvine, Calif.–based cardio devices company said yesterday that it plans to introduce the new Sapien 3 Ultra valve during the event, which runs until tomorrow. Edwards officials expect the Sapien 3 Ultra to receive CE Mark

Theraclion makes strides with echotherapy in Germany, Hong Kong

Theraclion (Malakoff, France) today announced wins when it comes to use of its echotherapy treatment in Germany and Hong Kong. The Heilfürsorge Bundespolizei (medical insurance of the federal German police force) now covers echotherapy for both breast fibroadenomas and thyroid nodules. “It is a strong mark of recognition for our technology that the German federal police

How Abbott is making good on investor promises

Abbott (NYSE: ABT) has won FDA approval of MR-compatible ICDs – an indication that it could be making good executing on key priorities it inherited when it acquired St. Jude Medical for $25 billion early this year. The news today “lends incremental credibility to our thesis that ABT can and will have a positive impact on STJ

Medtech stories we missed this week: Sept. 22, 2017

From the FDA’s clearance of Covalon’s film-drape to Bioventus launching its study, here are seven medtech stories we missed this week but thought were still worth mentioning. 1. FDA clears Covalon’s MediClear OTC surgical film-drape Covalon announced in a Sept. 21 press release that the FDA has cleared its MediClear PreOp to market in U.S. hospitals,

This Dräger newborn incubator focuses on ‘intact survival’

The latest in incubator technology from Dräger focuses on long-term health and quality of life, as well as survival. One device paying particular attention to these trends is the Babyleo TN500 IncuWarmer beds from Dräger. Florida Hospital announced it’s the first in the United States to implement the Babyleo beds. The beds are being used in

This pen can diagnose cancer in tissue in seconds

Scientists and engineers in Texas have created a pen-like device that can accurately recognize cancer in tissues during surgery. A team at the University of Texas at Austin has invented a tool used during surgeries that can give results in about 10 seconds, which is 150 times faster than current technology, according to the researchers.

How to design a successful embolic protection devices clinical trial

Embolic protection devices could reduce risks of interventional cardiac procedures such as TAVR, but their efficacy is hard to prove. David Novotny, Novella Clinical The embolic protection device (EPD) market is expected to grow into a billion-dollar industry if the device becomes the standard safety protocol for transcatheter aortic valve replacement (TAVR) and other interventional

Medtech stories we missed this week: Sept. 15, 2017

From Acera Surgical and Telos Medical’s partnership to Xtant Medical’s 510(k) clearance, here are seven medtech stories we missed this week but thought were still worth a mention. 1. Acera Surgical partners with Telos Medical for Restrata wound matrix trial Telos Partners announced in a Sept. 14 press release that Acera Surgical has chosen Telos to

Medtech stories we missed this week: September 8, 2017

From BrainScope’s pediatric traumatic brain injury assessment device to EOS Imaging releasing new surgery planning software, here are seven medtech stories we missed this week but thought were still worth a mention. 1. BrainScope to develop pediatric traumatic brain injury assessment device BrainScope announced in a Sept. 7 press release that it will immediately start creating

Cambridge Medical Robotics unveils first look at Versius ‘bot

Cambridge Medical Robotics released the first photos today of its surgical robot, Versius, designed to make minimal access surgery more widely available and easier to perform. “We’ve designed Versius with surgeons in mind. By equipping them with a remarkable tool, fit for their demanding job, we can change the way surgery is delivered,” CEO Martin…

GI Dynamics CEO is optimistic about Endobarrier’s future: Here’s why

GI Dynamics (ASX:GID) CEO Scott Schorer has had an uphill battle over the past year. His company has faced regulatory and compliance issues, negative shareholder sentiment and a number of other concerns. But Schorer and his team are committed to righting the ship and saving a product they see as having no equal in the current

PeekMed receives CE Mark and ISO certification

PeekMed (Braga, Portugal) recently announced that it has received ISO 13485 certification and CE Mark for its flagship 3D pre-operative system for orthopedic surgeons. The new CE Mark allows PeekMed to sell its system in Europe. It is currently working on obtaining FDA 510(k) approval to market in the U.S. PeekMed helps orthopedic surgeons plan

Cells can be programmed into living devices: Here’s how

Synthetic biologists at Harvard University have programmed microbial cells into living devices that can produce drugs, fine chemicals and biofuels and detect disease-causing agents. A team of biologists at Harvard’s Wyss Institute for Biologically Inspired Engineering fit cells with artificial molecular machinery that could sense stimuli like toxins in the environment, metabolite levels and inflammatory

FDA approves pivotal study of Vascular Dynamics MobiusHD high blood pressure device

Vascular Dynamics said today that the FDA approved an investigational device exemption for a clinical trial of its MobiusHD device for treating resistant hypertension. MobiusHD is designed to help regulate blood pressure using electrodes implanted in the carotid artery to stimulate baroreceptors there. Mountain View, Calif.–based Vascular Dynamics said the 300-patient Calm 2 study is designed

Allergan gel-based stents are treating glaucoma

An Allergan-developed gelatin-based stent is showing potential to treat glaucoma in a quicker and safer environment, according to new research from the University of Michigan. Glaucoma is a disease that damages the eye’s optic nerve and can cause vision loss and blindness. Medicines in the form of eyedrops or pills can be used to treat